China NMPA Product Recall - Infusion pump

Zhejiang Maidikang Medical Device Co., Ltd. issued a voluntary Level III recall for its infusion pumps on August 20, 2019. This significant action was taken after a national medical device quality supervision and spot check identified a critical non-compliance: the product's audible and visual alarm signals failed to meet established technical requirements. The inability of the alarm system to function as specified represents a potential safety concern, as these alarms are crucial for indicating operational issues or patient-related problems during infusion therapy, thus safeguarding patient well-being. The affected infusion pumps are designated under Registration Certificate No.: Zhexiezhuzhun 20182140436. The recall, managed by the company, operates under the regulatory guidance of the National Medical Products Administration (NMPA) and was reported through the Zhejiang Provincial Drug Administration. This demonstrates the company's adherence to regulatory frameworks after identifying a product defect. Required actions include the active removal of these devices from circulation to mitigate risks. Specific details concerning product numbers, specifications, and batch numbers are comprehensively documented in the "Medical Device Recall Event Report Form" associated with this event.